Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence

NCT04042155 UNKNOWN

MACACOD is a clinical record in the usual clinical practice of direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban). Design: single-center, observational, prospective, uncontrolled study of anticoagulated patients with any direct oral anticoagulant (DOAC) with atrial fibrillation or venous thromboembolism to determine the incidence of serious complications (thromboembolic or hemorrhagic) in real life

Details

Lead sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Status	UNKNOWN
Enrolment	1600
Start date	2019-07-29
Completion	2024-08

Conditions

• Atrial Fibrillation
• Recurrent Venous Thromboembolism

Interventions

• dabigatran, rivaroxaban, apixaban or edoxaban

Primary outcomes

• Thromboembolic events — 3 years
  Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
• Major haemorrhagic events — 3 years
  Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale Full scale name: Bleeding Assessment Research Consortium Scale ranges: 0-5 Where 0 is the better result and 5 is the worst

Countries

Spain